A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes

Treatments: Drug: LY2963016; Drug: Insulin Lispro; Drug: Lantus®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03338023

I4L-GH-ABES (Other Identifier)

16036

Details and patient eligibility

About

The purpose of this study is to compare long-acting basal insulin analog LY2963016 to Lantus® in combination with mealtime insulin lispro in adult Chinese participants with Type 1 Diabetes Mellitus (T1DM).

Enrollment: 272 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have T1DM based on the disease diagnostic criteria (World Health Organization [WHO] Classification).
• Have duration of T1DM ≥1 year.
• Have HbA1c ≤11 %.
• Have been administered with basal-bolus insulins or pre-mixed insulins for at least 90 days prior to screening.
• Have a body mass index (BMI) ≤35 kilograms per meter squared.

Exclusion criteria

• Exposure to an insulin glargine other than Lantus® within previous 30 days.
• Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study.
• Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within 6 months prior to entry into the study.
• Have known hypersensitivity or allergy to any of the study insulins (Lantus® or insulin lispro) or to excipients of the study insulins.
• Are pregnant, intend to become pregnant during the course of the study.
• Women who are breastfeeding.
• Are currently taking traditional medicine (herbal medicine or patent medicine) with known/specified content of anti-hyperglycemic effects within 3 months before screening.
• Have congestive heart failure Class III and IV.
• Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease.
• Have any active cancer.
• Have a history or diagnosis of human immunodeficiency virus (HIV) infection.
• Have presence of clinically significant gastrointestinal disease.
• Have a history of renal transplantation, or are currently receiving renal dialysis.
• Are receiving chronic systemic glucocorticoid therapy at pharmacological doses.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

272 participants in 2 patient groups

LY2963016 + Insulin Lispro

Experimental group

Description:

Participants received 100 units per milliliter (U/mL) LY2963016 administered subcutaneously (SC) once daily (QD) and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.

Treatment:

Drug: Insulin Lispro

Drug: LY2963016

Lantus® + Insulin Lispro

Active Comparator group

Description:

Participants received 100 U/mL Lantus® administered SC QD and 100 U/mL premeal insulin lispro administered SC thrice-daily (TID) within 15 minutes before meals or immediately after the meal.

Treatment:

Drug: Lantus®

Drug: Insulin Lispro